SUTURE-CLOSURE OMENTOPEXY VERSUS OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER

NCT06550856 | Recruiting

• 1 other identifier: Soh-Med-24-07-07MS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The present study will be conducted to assess whether there is a direct benefit associated with modified-Graham's omentopexy (MGO), above and beyond the benefit associated with Graham's omentopexy (GO) in the treatment of perforated duodenal ulcers. We attempted to answer the question whether primary closure of the perforation in MGO will affect the outcome of surgery. Complication rates will be compared for the two alternative surgical procedures.

Conditions

Perforated Peptic Ulcer

Outcome Measures

Primary Outcomes (1)

• Early postoperative follow up for repair of perforated peptic ulcer

  resumption of oral intake

  Three days after the operation

Study Arms (2)

SUTURE-CLOSURE OMENTOPEXY IN REPAIR OF PERFORATED PEPTIC ULCER

ACTIVE COMPARATOR

Group (A ) includes modification of the Graham's patch will be used in this group, where suitable sutures are passed between the edges of perforation and tied to close the perforation. A pedicle of omentum based on right omental artery is brought between these sutures, and these sutures are tied again with pedicle of omentum between knots over the perforation (thus the omentum remains sandwiched between the two levels of secured knots).

Procedure: SUTURE-CLOSURE OMENTOPEXY IN REPAIR OF PERFORATED PEPTIC ULCER

OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER

ACTIVE COMPARATOR

Group (B) includes Grahm's technique of omentopexy will be performed by closing the perforation by placing interrupted full thickness suitable sutures along the margins of the ulcer with a patch of pedicled omentum laid over these sutures, which are then tied (without any attempt for primary closure of the perforation before placing the omentum as a plug).

Procedure: OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER

Interventions

SUTURE-CLOSURE OMENTOPEXY IN REPAIR OF PERFORATED PEPTIC ULCER PROCEDURE

Patients presented with perforated peptic ulcer will be repaired using full thickness suture closure using 3/0 vicryl suture then omental patch laied over the sutures.

SUTURE-CLOSURE OMENTOPEXY IN REPAIR OF PERFORATED PEPTIC ULCER

OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER PROCEDURE

Patients presented with perforated peptic ulcer will be repaired by using omental patch without any attempt for primary closure of perforation.

OMENTOPEXY ALONE IN REPAIR OF PERFORATED PEPTIC ULCER

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- All adult patients of both sexes with a clinical diagnosis of perforated peptic ulcer (gastric or duodenal) that are fit to undergo surgery.

You may not qualify if:

• \- 1. Patients with associated bleeding ulcer (additional steps are needed to control bleeding).
• \. Patients with associated pathology other than perforated peptic ulcer that needs surgical intervention.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university Hospital

Sohag, Egypt

RECRUITING

Related Publications (3)

• Berne TV, Donovan AJ. Nonoperative treatment of perforated duodenal ulcer. Arch Surg. 1989 Jul;124(7):830-2. doi: 10.1001/archsurg.1989.01410070084017.

  PMID: 2742484 BACKGROUND

• Boey J, Choi SK, Poon A, Alagaratnam TT. Risk stratification in perforated duodenal ulcers. A prospective validation of predictive factors. Ann Surg. 1987 Jan;205(1):22-6. doi: 10.1097/00000658-198701000-00005.

  PMID: 3800459 BACKGROUND

• Chung KT, Shelat VG. Perforated peptic ulcer - an update. World J Gastrointest Surg. 2017 Jan 27;9(1):1-12. doi: 10.4240/wjgs.v9.i1.1.

  PMID: 28138363 BACKGROUND

MeSH Terms

Conditions

Peptic Ulcer Perforation

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Central Study Contacts

Adel A Abdrabou, Resident

CONTACT

01014910091; adelosman3399@gmail.com

Asem Elsani M Ali, Professor

CONTACT

0100 2613245

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in the Department of General Surgery, oncological and Laparoscopic Surgery Sohag University Hospital

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 13, 2024
• Study Start: July 15, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: August 13, 2024

Record last verified: 2024-08

Locations

EG (1)